BOX WARNING
Drug Dependence
METADATE CD should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
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METADATE CD SUMMARY
METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component.
Attention Deficit Hyperactivity Disorder (ADHD): METADATE® CD (methylphenidate HCl, USP) Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of METADATE CD in the treatment of ADHD was established in one controlled trial of children aged 6 to 15 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY).
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet
activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations: Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program: METADATE CD is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use: The effectiveness of METADATE CD for long-term use, i.e., for more than 3 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use METADATE CD for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE and ADMINISTRATION).
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NEWS HIGHLIGHTS
Published Studies Related to Metadate CD (Methylphenidate)
The Effect of Methylphenidate on Fatigue in Advanced Cancer: An Aggregated N-of-1
Trial. [2015]
advanced cancer... CONCLUSION: MPH does not improve fatigue in the population of patients with
Drug-specific laterality effects on frontal lobe activation of atomoxetine and
methylphenidate in attention deficit hyperactivity disorder boys during working
memory. [2014]
CONCLUSIONS: The study shows both shared and drug-specific effects. ATX
Long-term (1 year) safety and efficacy of methylphenidate modified-release
long-acting formulation (MPH-LA) in adults with attention-deficit hyperactivity
disorder: a 26-week, flexible-dose, open-label extension to a 40-week,
double-blind, randomised, placebo-controlled core study. [2014]
26-week, open-label extension phase of the same study (NCT01338818)... CONCLUSIONS: In adult patients with ADHD, use of MPH-LA up to 1 year continued to
Effect of extended-release dexmethylphenidate and mixed amphetamine salts on
sleep: a double-blind, randomized, crossover study in youth with
attention-deficit hyperactivity disorder. [2014]
measures of sleep... CONCLUSIONS: Higher stimulant doses were associated with reduced sleep duration
A randomized, double-blind, placebo-controlled, parallel-group study to evaluate
the efficacy and safety of osmotic-controlled release oral delivery system
methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in
Japan. [2014]
attention-deficit/hyperactivity disorder (ADHD)... CONCLUSIONS: OROS MPH in a dose range of 18-72 mg once daily was effective and
Clinical Trials Related to Metadate CD (Methylphenidate)
Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD [Completed]
Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana
(methylphenidate) patch for a longer time then 9 hours, many children report short sleep
latencies and better quality of sleep.
Methylphenidate Study in Breast or Gastrointestinal Cancer Patients [Terminated]
The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl
(Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma,
myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have
completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug
will also be studied. Another goal of the study is to see how certain cytokines change
while patients undergo chemotherapy or hormonal treatment.
The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease. [Terminated]
This project aims to determine if methylphenidate can improve deficits in attention and
symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with
Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on
postural control in these patients, a debilitating motor symptom that places patients at an
increased risk of falling. This study will build on existing data to support a new
indication for the use of methylphenidate in Parkinson's Disease. Using standard and
objective evaluations, this study will quantify the effect of methylphenidate at two doses
on attention levels, orthostatic hypotension, and measures of postural control. Phase I of
the study will compare methylphenidate 10mg three times daily to placebo and Phase II of the
study, for those tolerating the lower dose in Phase I, will compare methylphenidate 20mg
three times daily to placebo. By incorporating two different doses, the study also seeks to
determine if any improvements are dose-related. Secondary endpoints will include safety
assessments (adverse event monitoring and vital signs) performed every 30 minutes following
supervised drug administration. Visual analog scales will be presented to each participant
before treatment and following the final dose of each treatment to assess changes in
fatigue. A secondary task will be added to postural tests to assess the influence of
cognitive processes. It is hypothesized that methylphenidate will demonstrate a significant
beneficial effect on all outcomes. It is projected that objective improvements will be
observed following treatment with methylphenidate at both doses (10 and 20mg three time
daily) when compared to placebo. It is further hypothesized that the effects will be
dose-related and therefore more profound with higher doses.
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study [Recruiting]
The purpose of this study is to determine whether Quillivant XR is effective in the
treatment of ADHD in children with Autism Spectrum Disorder (ASD).
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD [Completed]
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference
to CONCERTA® in pediatric subjects diagnosed with ADHD.
Reports of Suspected Metadate CD (Methylphenidate) Side Effects
Contusion (3),
Head Injury (3),
Delusion (3),
Suicidal Ideation (3),
Mania (3),
Malaise (3),
TIC (3),
Dystonia (3),
Euphoric Mood (3),
Insomnia (3), more >>
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Page last updated: 2015-08-10
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